Polypoid Choroidal Vasculopathy (PCV)Phase 4NCT03244657
Phase IV Clinical Trial (STAR Study) Extension Study of Conbercept Ophthalmic Injection for Treatment of Polypoid Choroidal Vasculopathy
A Phase 4 study testing conbercept ophthalmic injection (0.5mg) in people with Polypoid Choroidal Vasculopathy (PCV), run by Chengdu Kanghong Biotech Co., Ltd. at 30 sites in China.
Trial summary
To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Polypoid Choroidal Vasculopathy (PCV)
- What is being tested?
- conbercept ophthalmic injection (0.5mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 30 sitesChina
- Study dates
- 25 Apr 2017to 28 Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Sign the informed consent and be willing to receive follow-up at the time specified in the trial; (2) A subject who has completed all visits specified by STAR study protocol and who is within 3 months after end of the last visit (the following subjects can be included: during STAR study, an investigator decided to discontinue treatment from point of view of safety, but the risk factor has disappeared or become stable).
- Note: Use the determined eye of STAR study as the target eye.
Who cannot join
- (1) A subject who actively withdrew from the study during STAR study; (2) The target eye or the body ever received other anti-VEGF drugs (such as Macugen, Lucentis, Avastin, Eylea, Zaltrap, etc.) from start of STAR study to before screening of this study.
- In the target eye or the body, there is any following disease and condition: an investigator thinks that if the subject participates in this study, the disease and condition (such as: the target eye has history of vitrectomy; blood pressure control of a hypertension patient is not ideal [ after treatment of antihypertensive drugs, blood pressure is still ≥ 150/95 mmHg]; AIDS; malignant tumors; active hepatitis; renal failure; severe mental, neurological, cardiovascular, respiratory and other systemic diseases; ankylosing spondylitis; systemic lupus erythematosus; heart stent surgery; and the like) may cause the subject to be at relatively large risk; (4) A subject who ever had stroke, transient ischemic attack, myocardial infarction, or acute congestive heart failure and other cardiovascular events within 6 months before screening (5) A subject who participated in any drug (not including vitamins or minerals) clinical trial within 3 months (if the test drug has long half-life and 5 half-lives > 3 months, then 5 half-lives are taken) before screening;(6) Not take effective contraceptive measure; Note: The following conditions are not excluded. I. Amenorrhea for 12 months under natural condition; or, under natural condition, amenorrhea for 6 months, accompanied with follicle stimulating hormone level in serum > 40 mIU/ml; II. 6 weeks after bilateral oophorectomy with/without hysterectomy;
- Use one or more of the following contraceptive methods:
- Sterilization (male with bilateral vasoligation, vasectomy)
- Hormone contraception (implantable type, patch type, oral administration type)
- Intrauterine device, double-barrier method IV. Be able to take reliable contraceptive measure throughout the study and insist on it till 30 days after discontinuation of the investigational drug (unacceptable contraceptive methods include: regular abstinence, i.e., depending on calendar, ovulatory period, body temperature measurement method and post-ovulation period method; coitus interruptus for extracorporeal spermiation). (7) Pregnant (in this trial, pregnancy is defined as positive urine pregnancy test), lactating females (8) A subject whom an investigator thinks needs to be excluded.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
China30 sites, 30 recruiting
- Not yet recruiting
Beijing Hospital
Beijin
Dai Hong
- Not yet recruiting
The Chinese people's liberation army 474 hospital
Beijin
Xiao Yun
- Not yet recruiting
Beijing Tongren Hospital,Cmu
Beijing
Zhang feng
- Not yet recruiting
Chinese Pla General Hospital
Beijing
Li Chaohui
- Not yet recruiting
Peking Union Medical College Hospital
Beijing
Chen Youxin
- Not yet recruiting
Peking University First Hospital
Beijing
Yang Liu
- Recruiting
Peking University People'S Hospital
Beijing
Li Xiaoxin
- Not yet recruiting
PEKING UNIVERSITY Third HOSPITAL
Beijing
Dou Hongliang
- Not yet recruiting
Xiangya Hospital Central South University
Changsha
XU Huizuo
- Not yet recruiting
Hainan Eye Hospital of Zhongshan Ophthalmic Center, Sun Yat-sen University
Hainan
Cheng Wangling
- Not yet recruiting
Hebei Eye Hospital
Hebei
Zhang Minglian
- Not yet recruiting
The Second Hospital of Hebei Medical University
Hebei
Ma Jingxue
- Not yet recruiting
Henan Province People's Hospital
Henan
Fan Ke
- Not yet recruiting
The Second Hospital of Jilin University
Jilin City
Su Guanfang
- Not yet recruiting
Lanzhou University Second Hospital
Lanzhou
Zhang Wenfang
- Not yet recruiting
Affiliated Eye Hospital of Nanchang University
Nanchang
Yi Jinglin
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanjing
Zhou Qiong
- Not yet recruiting
The First Affiliated Hospital With Nanjing Medical University
Nanjing
Liu Qinghuai
- Not yet recruiting
Eye&Ent Hospital of Fudan University
Shanghai
Zhang Yongjin
- Not yet recruiting
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai
Liu Lin
- Not yet recruiting
Shanghai General Hospital
Shanghai
Yu Suqin
- Not yet recruiting
Stu/Cuhk Joint Shantou International Eye Center
Shantou
Cheng Weiqi
- Not yet recruiting
Shanxi Eye Hospital
Shanxi
Jia Yading
- Not yet recruiting
Shenzhen Eye Hospital
Shenzhen
Cheng Qingshan
- Not yet recruiting
Tianjin Medical University Eye Hospital
Tianjin
Li Xiaorong
- Not yet recruiting
The Eye Hospital of Wmu Zhejiang Eye Hospital
Wenzhou
Liu Xiaoling
- Not yet recruiting
Renmin Hospital of Wuhan University
Wuhan
Xing Yiqiao
- Not yet recruiting
Xiamen Eye Centre of Xiamen University
Xiamen
Wu Guoji
- Recruiting
Ningxia Peple'S Hospital
Yinchuan
Ha Shaoping
- Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang
Yao ke
About this study
To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects.
- Conditions
- Polypoid Choroidal Vasculopathy (PCV)
- Being tested
- conbercept ophthalmic injection (0.5mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conbercept ophthalmic injection (0.5mg)Drug
The target eye receives intravitreal injection of 0.5mg conbercept ophthalmic injection once every 12 weeks; if a subject meets "additional drug administration criteria" within 12 weeks between treatments, the subject can receive additional injection treatment
conbercept ophthalmic injection (0.5mg)Drug
In principle, the first administration time of the target eye uses the time determined by the assessment at end of STAR study; later, based on "treatment-extension drug administration criteria", an investigator determines next visit time/treatment interval according to assessment result at each visit.When a subject's visit/treatment interval extends to 12 weeks, an additional safety visit can be arranged if an investigator considers that there is suspicious active lesion; if assessment result at the safety visit meets "additional drug administration criteria", additional injection treatment can be given.
| Study group | Role | What they receive |
|---|---|---|
| Q12W group | Experimental | Not described Receives: Drug: conbercept ophthalmic injection (0.5mg) |
| TAE group | Experimental | Not described Receives: Drug: conbercept ophthalmic injection (0.5mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of best corrected visual acuity (BCVA)
Assess mean of change of best corrected visual acuity (BCVA) compared with baseline in the target eyes (using the same target eyes as STAR study) of subjects at end of the extension study;
Measured: up to 40 week
adverse events
Assess incidence and severity of adverse events in subjects.
Measured: up to 40 week
Secondary outcomes (4)
mean of change of BCVA
Assess mean of change of BCVA compared with that in STAR study baseline (before treatment) in the target eyes of subjects at end of the extension study
Measured: up to 40 week
change of central retinal thickness (CRT)
Assess mean of change of central retinal thickness (CRT) compared with baseline in the target eyes of subjects at time of each visit till end of the extension study;
Measured: up to 40 week
mean of change of lesion's maximum retinal thickness (MRT)
Assess mean of change of lesion's maximum retinal thickness (MRT), retinal pigment epithelium detachment's (PED) volume and thickness, polypoid lesion area, retinal hemorrhage area and other imaging indicators compared with baseline in the target eyes of subjects at end of the extension study;
Measured: up to 40 week
average number of times of drug administration
Assess average number of times of drug administration in two groups of subjects during the extension treatment;
Measured: up to 40 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start25 Apr 2017
- Primary completion31 Oct 2019 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypoid Choroidal Vasculopathy (PCV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244657
- Sponsor's protocol ID
- KH902-STE-CRP-1.2
- Status last verified
- Jul 2017
- First submitted
- 7 Aug 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Trial (STAR Study) Extension Study of Conbercept Ophthalmic Injection for Treatment of Polypoid Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT03244657
- Acronym / sponsor ID
- KH902-STE-CRP-1.2
- Conditions
- Polypoid Choroidal Vasculopathy (PCV)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Q12W group | Experimental | Drug: conbercept ophthalmic injection (0.5mg) |
| TAE group | Experimental | Drug: conbercept ophthalmic injection (0.5mg) |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (1) Sign the informed consent and be willing to receive follow-up at the time specified in the trial; (2) A subject who has completed all visits specified by STAR study protocol and who is within 3 months after end of the last visit (the following subjects can be included: during STAR study, an investigator decided to discontinue treatment from point of view of safety, but the risk factor has disappeared or become stable).
- Note: Use the determined eye of STAR study as the target eye.
Key exclusion criteria (6 listed)
- (1) A subject who actively withdrew from the study during STAR study; (2) The target eye or the body ever received other anti-VEGF drugs (such as Macugen, Lucentis, Avastin, Eylea, Zaltrap, etc.) from start of STAR study to before screening of this study.
- Use one or more of the following contraceptive methods:
- Sterilization (male with bilateral vasoligation, vasectomy)
- Hormone contraception (implantable type, patch type, oral administration type)
- Intrauterine device, double-barrier method IV. Be able to take reliable contraceptive measure throughout the study and insist on it till 30 days after discontinuation of the investigational drug (unacceptable contraceptive methods include: regular abstinence, i.e., depending on calendar, ovulatory period, body temperature measurement method and post-ovulation period method; coitus interruptus for extracorporeal spermiation). (7) Pregnant (in this trial, pregnancy is defined as positive urine pregnancy test), lactating females (8) A subject whom an investigator thinks needs to be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conbercept ophthalmic injection (0.5mg)The target eye receives intravitreal injection of 0.5mg conbercept ophthalmic injection once every 12 weeks; if a subject meets "additional drug administration criteria" within 12 weeks between treatments, the subject can receive additional injection treatment | Drug | Q12W group |
| conbercept ophthalmic injection (0.5mg)In principle, the first administration time of the target eye uses the time determined by the assessment at end of STAR study; later, based on "treatment-extension drug administration criteria", an investigator determines next visit time/treatment interval according to assessment result at each visit.When a subject's visit/treatment interval extends to 12 weeks, an additional safety visit can be arranged if an investigator considers that there is suspicious active lesion; if assessment result at the safety visit meets "additional drug administration criteria", additional injection treatment can be given. | Drug | TAE group |
Primary outcome
change of best corrected visual acuity (BCVA)
Time frame: up to 40 week
Assess mean of change of best corrected visual acuity (BCVA) compared with baseline in the target eyes (using the same target eyes as STAR study) of subjects at end of the extension study;
adverse events
Time frame: up to 40 week
Assess incidence and severity of adverse events in subjects.
4 secondary outcomes
mean of change of BCVA
Time frame: up to 40 week
change of central retinal thickness (CRT)
Time frame: up to 40 week
mean of change of lesion's maximum retinal thickness (MRT)
Time frame: up to 40 week
average number of times of drug administration
Time frame: up to 40 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
Related trials for Polypoid Choroidal Vasculopathy (PCV)
Not yet recruitingPhase 3
Adjunct Episcleral Brachytherapy for PCV
Age-Related Macular Degeneration, Polypoid Choroidal Vasculopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing conbercept ophthalmic injection (0.5mg) in people with Polypoid Choroidal Vasculopathy (PCV), run by Chengdu Kanghong Biotech Co., Ltd. at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li xiaoxing (+86-13801153661, dr_lixiaoxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of best corrected visual acuity (BCVA) (time frame: up to 40 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.